Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

• ClinicalTrials.gov Identifier: NCT00258856
• Recruitment Status: Completed
• First Posted: November 28, 2005
• Results First Posted: November 25, 2009
• Last Update Posted: February 14, 2014
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: Meningitis; Meningococcal Infection
• Intervention: Biological: Polysaccharide Diphtheria Conjugate Vaccine
• Enrollment: 234

Participant Flow

Recruitment Details	Participants were recruited in 18 US clinic sites from 14 January 2006 through 05 June 2006.
Pre-assignment Details	A total of 234 participants that met the inclusion but none of the exclusion criteria were enrolled and vaccinated.

Arm/Group Title	Menactra® Group 1	Menactra® Group 2	Meningococcal Vaccine-naïve Group 3	Meningococcal Vaccine-naïve Group 4
Arm/Group Description	Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination	Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination	Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.	Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
Period Title: Overall Study
Started	59	58	58	59
Completed	56	58	56	58
Not Completed	3	0	2	1
Reason Not Completed
Lost to Follow-up	1	0	2	0
Non-compliance	2	0	0	1

Baseline Characteristics

Arm/Group Title		Menactra® Group 1	Menactra® Group 2	Meningococcal Vaccine-naïve Group 3	Meningococcal Vaccine-naïve Group 4	Total
Arm/Group Description		Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination	Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination	Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.	Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination	Total of all reporting groups
Overall Number of Baseline Participants		59	58	58	59	234
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	58 participants	58 participants	59 participants	234 participants
	<=18 years	59 100.0%	58 100.0%	58 100.0%	59 100.0%	234 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	59 participants	58 participants	58 participants	59 participants	234 participants
		9.9 (2.56)	10.6 (2.60)	11.7 (2.27)	11.9 (2.06)	11.0 (2.51)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	58 participants	58 participants	59 participants	234 participants
	Female	26 44.1%	22 37.9%	25 43.1%	23 39.0%	96 41.0%
	Male	33 55.9%	36 62.1%	33 56.9%	36 61.0%	138 59.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	59 participants	58 participants	58 participants	59 participants	234 participants
		59	58	58	59	234

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.
Description	Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Time Frame	7 or 14 days post-vaccination

Outcome Measure Data

Analysis Population Description

Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.

Arm/Group Title	Menactra® Group 1	Menactra® Group 2	Meningococcal Vaccine-naïve Group 3	Meningococcal Vaccine-naïve Group 4
Arm/Group Description:	Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination	Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination	Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.	Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
Overall Number of Participants Analyzed	56	58	56	58
Measure Type: Number; Unit of Measure: Percentage of participants
Meningococcal serogroup A - PRE	84	89	47	59
Meningococcal serogroup A - POST	100	100	100	100
Meningococcal serogroup C - PRE	62	58	39	47
Meningococcal serogroup C - POST	100	100	98	96
Meningococcal serogroup Y - PRE	96	96	87	98
Meningococcal serogroup Y - POST	100	100	100	100
Meningococcal serogroup W-135 - PRE	81	84	31	36
Meningococcal serogroup W-135 - POST	100	100	100	98

Adverse Events

Time Frame	28 days post-vaccination
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Menactra® Group 1		Menactra® Group 2		Meningococcal Vaccine-naïve Group 3		Meningococcal Vaccine-naïve Group 4
Arm/Group Description	Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination		Participants received Menactra® in Study 603-02. Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination		Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.		Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
All-Cause Mortality
	Menactra® Group 1		Menactra® Group 2		Meningococcal Vaccine-naïve Group 3		Meningococcal Vaccine-naïve Group 4
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	Menactra® Group 1		Menactra® Group 2		Meningococcal Vaccine-naïve Group 3		Meningococcal Vaccine-naïve Group 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0.00%)		0/58 (0.00%)		0/58 (0.00%)		0/59 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.0%
	Menactra® Group 1		Menactra® Group 2		Meningococcal Vaccine-naïve Group 3		Meningococcal Vaccine-naïve Group 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/58 (22.41%)		20/58 (34.48%)		14/58 (24.14%)		15/59 (25.42%)
Gastrointestinal disorders
Abdominal pain upper * 1	3/58 (5.17%)	3	5/58 (8.62%)	6	5/58 (8.62%)	5	1/59 (1.69%)	1
Diarrhoea * 1	2/58 (3.45%)	2	2/58 (3.45%)	2	1/58 (1.72%)	1	5/59 (8.47%)	5
Vomiting * 1	3/58 (5.17%)	3	3/58 (5.17%)	3	2/58 (3.45%)	2	2/59 (3.39%)	2
General disorders
Pyrexia * 1	3/58 (5.17%)	3	2/58 (3.45%)	2	1/58 (1.72%)	2	3/59 (5.08%)	3
Infections and infestations
Nasopharyngitis * 1	1/58 (1.72%)	1	3/58 (5.17%)	3	2/58 (3.45%)	2	0/59 (0.00%)	0
Otitis media * 1	1/58 (1.72%)	1	3/58 (5.17%)	3	1/58 (1.72%)	1	0/59 (0.00%)	0
Rhinitis * 1	1/58 (1.72%)	1	3/58 (5.17%)	3	0/58 (0.00%)	0	1/59 (1.69%)	1
Nervous system disorders
Headache * 1	1/58 (1.72%)	2	2/58 (3.45%)	2	3/58 (5.17%)	4	3/59 (5.08%)	3
Respiratory, thoracic and mediastinal disorders
Cough * 1	0/58 (0.00%)	0	3/58 (5.17%)	3	4/58 (6.90%)	4	3/59 (5.08%)	3
Pharyngolaryngeal pain * 1	3/58 (5.17%)	3	1/58 (1.72%)	1	4/58 (6.90%)	4	4/59 (6.78%)	4
Upper respiratory tract congestion * 1	1/58 (1.72%)	1	2/58 (3.45%)	2	3/58 (5.17%)	3	2/59 (3.39%)	2
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 7.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.

Results Point of Contact

• Name/Title: Medical Director
• Organization: Sanofi Pasteur Inc.
• EMail: RegistryContactUs@sanofipasteur.com

• Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT00258856
• Other Study ID Numbers: MTA23
• First Submitted: November 24, 2005
• First Posted: November 28, 2005
• Results First Submitted: October 19, 2009
• Results First Posted: November 25, 2009
• Last Update Posted: February 14, 2014